Device for detecting analytes in fluid samples

ABSTRACT

The present invention provides a device ( 100 ) for detecting the presence of an analyte in a liquid sample. The device ( 100 ) has an opening ( 115 ) for introducing the liquid sample into a first chamber ( 301 ) for collecting the liquid sample, and a second chamber ( 601 ) connected to the first chamber ( 301 ) by a passageway ( 205 ) and containing a test element. The device also has a third chamber ( 701 ) connected to the second chamber ( 601 ) by a channel and containing a movable member ( 311 ) having first and second positions. The third chamber ( 701 ) is divided by the movable member ( 311 ) into first ( 901 ) and second ( 902 ) zones, and the first zone ( 901 ) has a vent hole ( 165 ). The movable member ( 311 ) is in contact with at least one wall of the third chamber ( 701 ) to prevent gas communication between the first and second zones ( 901, 902 ).

FIELD OF THE INVENTION

The present invention relates to devices for the detection of analytesin fluid samples.

BACKGROUND OF THE INVENTION

The following Background of the Invention is intended to aid the readerin understanding the invention and is not admitted to be prior art.

In the health-care industry, diagnostic testing of body fluids is acommon place activity. Employers, government agencies, sports teams andother organizations have also become increasingly involved in diagnostictesting to maintain safety in the workplace and to ensure compliancewith laws, rules and regulations.

It is generally necessary to utilize devices for collecting body fluids,such as urine, and to detect the presence of a predetermined analyte(e.g. a drug and/or metabolite thereof, or an indicator of disease).Such testing devices generally require that a sample be placed in asample container and that a technician manually insert and submerge aportion of a testing strip into the sample, and then withdraw it to readthe result. With the potential for contact with the sample by thetechnician and its associated health and contamination risks, a sealedreceptacle for preventing contact is desirable. Various means have beenproposed for reducing the risk of contact as shown in U.S. Pat. No.4,976,923, U.S. Pat. No. 5,429,804, and U.S. Pat. No. 6,726,879, whichutilize testing devices having test strips mounted in their lids. Inuse, the container is inverted or tilted so that the sample can wet thestrips to perform the test.

Recently, the use of testing devices by other than health careprofessionals has increased. Due to the fact that these tests areincreasingly performed and evaluated by relatively unskilledtechnicians, the device should be simple to operate to ensure adequatesubmersion of the test strip and provide accurate results.

Therefore, a continuing need exists for testing devices that requireminimum manual operation while ensuring accurate and reliable testresults.

SUMMARY OF THE INVENTION

The present invention provides a device for detecting the presence of ananalyte in a liquid sample. The device has an opening for introducingthe liquid sample into a first chamber for collecting the liquid sample,and a second chamber connected to the first chamber by a passageway andcontaining a test element. The device also has a third chamber connectedto the second chamber by a channel and containing a movable memberhaving first and second positions. The third chamber is divided by themovable member into first and second zones, and the first zone has avent hole. The movable member is in contact with at least one wall ofthe third chamber to prevent gas communication between the first andsecond zones.

In one embodiment the device can also have a lid for closing theopening. The test element can be an assay card containing one or moreassay test strips.

In one embodiment of the device the movable member is a plunger. Theplunger can contain a seal in contact with at least one wall of thethird chamber to prevent gas communication between the first and secondzones of the third chamber. The third chamber can also have a bottom,and in one embodiment the vent hole is situated on the bottom of thethird chamber. In one embodiment the plunger has a push bar extendingtowards the opening of the container. The lid can have a surface thatcontacts and depresses the push bar when the lid is applied to theopening.

In various embodiments of the device the passageway has a diameter ofless than 10 mm, or less than 9 mm, or less than 8 mm, or less than 7mm, or less than 6 mm, or less than 5 mm, or less than 4 mm, or lessthan 3 mm.

In another aspect the present invention provides methods for detectingthe presence of an analyte in a liquid sample. The methods involveintroducing a liquid sample into a test device as described herein,causing the movable member to move from the first position to the secondposition and thereby causing a volume of air to be drawn from the secondchamber into the third chamber, and thereby causing a volume of liquidto be drawn from the first chamber through the passageway and into thesecond chamber to contact the test element, and detecting the presenceof the analyte in the sample.

In one embodiment the methods involve contacting the lid with the pushbar and depressing the push bar as the lid is applied to the device, andthereby causing the movable member to move from the first position tothe second position. In one embodiment depressing the push bar andmoving the movable member from the first position to the second positioncauses a negative air pressure gradient to form in the third chamber andthe volume of air to be drawn from the second chamber into the thirdchamber. The movement of the volume of air from the second chamber tothe third chamber can be the cause of a negative air pressure gradientforming in the second chamber. By formation of a negative air pressuregradient is meant that a vacuum forms in one chamber, causing air to be“pulled” into the chamber from another chamber in order to fill thevacuum created. The air pressure gradient refers to a difference ininternal air pressures between two chambers.

In one embodiment the negative air pressure gradient in the secondchamber causes the fluid sample to flow from the first chamber throughthe passageway to the second chamber, and thereby to contact the testelement. Depressing the push bar and moving the movable member from thefirst position to the second position can cause a volume of air toescape from the first zone through the vent hole.

The summary of the invention described above is not limiting and otherfeatures and advantages of the invention will be apparent from thefollowing detailed description, as well as from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of the device in accordance withthe present invention.

FIG. 2 is another exploded perspective view of the device in accordancewith the present invention from a different aspect.

FIG. 3 is a perspective view of the device in accordance with thepresent invention with a lid removed.

FIG. 4 is a perspective view of the device in accordance with thepresent invention with a base removed.

FIG. 5 is a cross-sectional view of the device in accordance with thepresent invention, wherein a liquid sample is received in both first andsecond chambers.

FIG. 6 is an enlarged partial view of FIG. 5, wherein the liquid sampleis not shown in order to clearly illustrate the structure of apassageway.

FIG. 7 is a cross-sectional view of the device in accordance with thepresent invention, showing a plunger is positioned at a first positionand the liquid sample is received in only the first chamber.

FIG. 8 is an enlarged partial view of FIG. 7, wherein the liquid sampleis not shown in order to clearly illustrate the structure of a channel.

FIG. 9 is a cross-sectional view similar to FIG. 7, wherein the plungeris positioned at a second position, and a portion of liquid sample hasflown into the second chamber.

DETAILED DESCRIPTION

The present invention provides devices and methods for determining thepresence or amount of an analyte in a liquid sample. In one embodimentthe device takes the form of a cup, which receives a liquid sample foranalysis. In one embodiment the liquid sample is urine. The analyte canbe any analyte, for example, glucose, a drug of abuse or a metabolitethereof.

The device utilizes a system of chambers to move liquid sample throughthe device and detect the presence or amount of an analyte in thesamples. In one embodiment the device has three chambers, and liquidsample can be moved from one chamber to another by force of airpressure. The surface tension of the liquid sample can be used to holdthe liquid in one chamber until the user is prepared to move the sampleto an adjacent chamber by application of air pressure to the chambers.In various embodiments the air pressure can take the form of an increaseor a decrease (e.g., formation of a vacuum) in internal air pressure.The different chambers of the device are connected by passageways,channels, and vent holes, which allow for the transfer of air pressureand liquid between the chambers. The device also has a movable membersituated in one of the chambers. In one embodiment the movable member isa plunger, and the chamber is a cylinder that houses the plunger. Whenthe plunger is moved from a first position to a second position, air isforced out of the third chamber and creates a vacuum that is transferredto the second chamber, which causes a break in surface tension of liquidsituated in the first chamber, and thereby causes liquid to flow fromthe first to the second chamber. By cylinder is meant a structurecontaining the movable member and within which the movable member ismoved from a first position to a second position. When the chamber is acylinder, it need not have a perfectly cylindrical shape in allembodiments, but can vary in shape and size, or take one shape at oneportion and another shape at another portion, as long as it stillperforms the functions required by the assay.

In one embodiment the test element of the device is situated in thesecond chamber and analysis of the liquid sample therefore begins. Inthe embodiment depicted in the Figures, the movable member has the formof a plunger-type structure having a generally cylindrical shape. But inother embodiments the movable member can take any suitable shape.

Analytes

A variety of analytes can be detected or quantified by the test elementsin the present invention. The analyte may be an infectious agent orindicative of an infected state. The analyte may be a drug (for examplea drug of abuse), a hormone, a protein, a nucleic acid molecule, anetiological agent, or a specific binding pair member. The term “drug ofabuse” (DOA) refers to a drug that is taken for non-medicinal reasons(usually for mind-altering effects). The abuse of such drugs can lead tophysical and mental damage and (with some substances) dependence,addiction and/or death. Examples of DOAs include cocaine; amphetamines(e.g., black beauties, white bennies, dextroamphetamines, dexies,beans); methamphetamines (crank, meth, crystal, speed); barbiturates(Valium®, Roche Pharmaceuticals, Nutley, N.J.); sedatives (i.e.sleep-aids); lysergic acid diethylamide (LSD); depressants (downers,goofballs, barbs, blue devils, yellow jackets, ludes); tricyclicantidepressants (TCA, e.g., imipramine, amitriptyline and doxepin);phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed,etc.); and opiates (e.g., morphine, opium, codeine, heroin, oxycodone).Legal drugs that are taken for medical reasons, but on which overdosecan easily occur may also be tested for using these test strips, forexample, tricyclic antidepressants (imipramine and the like) and overthe counter products containing acetaminophen.

Test Elements

The test element can conveniently be selected as lateral flow teststrips, which are widely available for testing a broad range ofanalytes. However, any suitable test element can be used in the presentinvention.

A variety of test elements can be incorporated into the presentinvention. One type of test element is a test strip. Test strips areavailable in a variety of formats, such as immunoassay or chemical testformat, for detecting analytes of interest in a sample, such as a drugof abuse or a metabolite suggestive of health status. Test strips canalso be configured for either noncompetitive or competitive assayformats. In some formats, the test strips have a bibulous materialhaving a sample application zone, a reagent zone, and a test resultzone. The sample is applied to the sample application zone and flowsinto the reagent zone by capillary action. In the reagent zone, thesample dissolves and mixes with reagents necessary for detection of theanalyte (if present). The sample, now carrying the reagents, continuesto flow to the test results zone. Additional reagents are immobilized inthe test results zone, such as a specific binding molecule for theanalyte. These reagents react with and bind the analyte (if present) orone of the first reagents from the reagent zone. Labels for providingthe detectable signal can be present in the reagent zone, or in aseparate label zone.

Typically, in noncompetitive formats, a signal is produced if the samplecontains the analyte, and no signal is produced if the analyte is notpresent. In competitive formats, a signal can be produced if no analyteis present, and no signal if analyte is present.

When the test element is a test strip, it may be made of bibulous ornon-bibulous material. A test strip can include more than one material,which are then in fluid communication. One material of a test strip maybe overlaid on another material of the test strip, such as for example,filter paper overlaid on nitrocellulose. Alternatively or in addition, atest strip may include a region comprising one or more materialsfollowed by a region comprising one or more different materials. In thiscase, the regions are in fluid communication and may or may notpartially overlap one another. The material or materials of the teststrip can be bound to a support or solid surface such as a supportingsheet of plastic, to increase its handling strength.

In embodiments where the analyte is detected by a signal producingsystem, such as by one or more enzymes that specifically react with theanalyte, one or more components of the signal producing system can bebound to the analyte detection zone of the test strip material in thesame manner as specific binding members are bound to the test stripmaterial, as described above. Alternatively or in addition, componentsof the signal producing system that are included in the sampleapplication zone, the reagent zone, or the analyte detection zone of thetest strip, or that are included throughout the test strip, may beimpregnated into one or more materials of the test strip. This can beachieved either by surface application of solutions of such componentsor by immersion of the one or more test strip materials into solutionsof such components. Following one or more applications or one or moreimmersions, the test strip material is dried. Alternatively or inaddition, components of the signal producing system that are included inthe sample application zone, the reagent zone, or the analyte detectionzone of the test strip, or that are included throughout the test strip,may be applied to the surface of one or more test strip materials of thetest strip as was described for labeled reagents.

The zones can be arranged as follows: sample application zone, one ormore reagent zones, one or more test results determination zones, one ormore control zones, one or more adulteration zones, and fluid absorbingzone. If the test results determination zone includes a control zone,preferably it follows the analyte detection zone of the test resultdetermination zone. All of these zones, or combinations thereof, can beprovided in a single strip of a single material. Alternatively, thezones are made of different materials and are linked together in fluidcommunication. For example, the different zones can be in direct orindirect fluid communication. In this instance, the different zones canbe jointed end-to-end to be in fluid communication, overlapped to be influid communication, or be communicated by another member, such ajoining material, which is preferably bibulous such as filter paper,fiberglass or nitrocellulose. In using a joining material, a joiningmaterial may communicate fluid from end-to-end joined zones or materialsincluding such zones, end-to-end joined zones or materials includingsuch zones that are not in fluid communication, or join zones ormaterials that include such zones that are overlapped (such as but notlimited to from top to bottom) but not in fluid communication.

Devices

Referring to FIGS. 1 and 2, the device of the invention can be used tocollect a body fluid, such as urine, and to detect the presence oramount of an analyte contained therein (e.g. a drug of abuse and/ormetabolite thereof). The device generally includes a container 111having an opening 115 for collecting the liquid sample, a lid 101 forclosing the opening, and at least one test element 137 for conducting atest. In one embodiment the lid 101 can be a lid that is screwed ontothe device to be secured in place, but in other embodiments the lid canbe snapped on or otherwise secured in place by any convenient means. Thedevice can also contain a seal 109 for sealing the container shut whenthe lid 101 is applied. Inside of the first container 111 is provided amovable member, such as a plunger 149 that is movably received in thecontainer 111.

The parts of the device can be formed or molded from any suitablematerial. For example, a variety of plastics can be used. Referring tothe embodiment illustrated in the Figures, the device includes acup-like main body 111 and a base 151 that can be hermetically attachedto a bottom of the main body 111. With reference to FIGS. 3, 5, 7, and9, the main body 111 has a number of vertical sidewalls 117 connected toeach other, a round upper rim 113 connecting top ends of the sidewalls,and a generally flat bottom wall 207 connecting lower ends of thesidewalls. In this embodiment two inner walls 309 extend generallyparallel to two adjacent sidewalls 117 and connect with them at top endsthereof, so as to define a second chamber 601, which contains the testelement. The upper rim 113 defines an opening 115 for introducing theliquid sample and can have threads that can mate with correspondingthreads on the lid 101 during coupling of the lid to the container 313.

The device has a movable member, which can create an air pressure vacuumin certain chambers of the device when it is moved from a first to asecond position. In the embodiment illustrated in the Figures, themovable member is a plunger 149. A plunger housing 311 is formed in theinterior of the main body 111 and in air communication with the secondchamber 211, which contains the test element. The plunger housing 311forms the third chamber. In this embodiment the plunger housing 311 isshaped like an inverted funnel and includes a cylindrical lower section303 opening at the bottom wall 207 of the main body 111 through a venthole. The plunger housing also has a cylindrical upper section 307 whichhas a diameter smaller than that of the lower section 303, and a taperedintermediate section 305 connecting the upper and lower sections. Asshown in FIG. 7 and detailed in FIG. 8, in this embodiment the lowersection 303 of the plunger housing is partially connected to one of theinner walls 309, and a channel 801 is defined in the connection area toallow air exchange between the third chamber 701 and the second chamber601. By two chambers being in “air communication” or “gas communication”is meant that a change in the air pressure in one chamber will cause anair pressure change in the other chamber, or that it will cause fluid tobe drawn into or expelled from one chamber to another, or that air isable to move between two (or more) chambers.

Chambers

The chambers of the device can be of any shape or form suitable tofulfill their function in the device. In one embodiment the thirdchamber can take a generally cylindrical, syringe-like, or funnel shape,but other shapes can also be used that can support the movable memberand the first and second zones of the third chamber. Also, the differentzones of the third chamber can also take different forms. Similarly, thesecond chamber can also take any shape that supports the test elements,and the first chamber can be of any shape that supports the introductionof liquid into the device.

The bottom wall 207 of the main body (which forms the bottom of thefirst chamber) contains a passageway 205 therein connecting the firstchamber to the second chamber 601. The passageway 205 has a diameterthat is too small to allow the fluid in the main body 111 to flowtherethrough under air pressure that is substantially equal toatmospheric pressure. Fluid will flow from the first chamber into thesecond chamber under a vacuum of air pressure induced by movement of themovable member. In various embodiments the diameter of the passageway isless than 10 mm, or less than 9 mm, or less than 8 mm, or less than 7mm, or less than 6 mm, or less than 5 mm, or less than 4 mm, or lessthan 3 mm, or even smaller. In one embodiment, the diameter of thepassageway 205 is about 4 mm, or about 5 mm, or about 3 mm, or 3-5 mm.While in the embodiment depicted the passageway is an opening betweenthe first and second chamber, the passageway can also have otherconfigurations. For example, in various embodiments the passageway canbe a sinuous groove defined in the bottom wall of the main body with asmall sectional diameter, or any opening or passageway connecting thetwo chambers. The bottom wall 207 further includes an embossment 209 ata bottom surface thereof around the opened area.

The base 151 can be permanently affixed to the main body 111. The base151 includes an upper wall 153, a bottom wall 213, and a fencing wall155 connecting the upper wall 153 and bottom wall 213. The fencing wall155 and bottom wall 213 together define a cavity 157 which is a part ofthe second chamber 601 and receives a portion of the liquid sample. Inthis embodiment a groove 159 is defined in a top of the fencing wall 155to engage with the embossment 209 on the bottom wall 207 of the mainbody 111. In assembling the main body 111 and the base 151, theembossment 209 can be embedded in the groove 159, and then an ultrasonicwelding can be used to hermetically seal these two components. Variousother methods can also be used to affix the base and the main body whileensuring a good seal therebetween. In various embodiments, thermalwelding, gluing, or compressive ring gaskets all can be used. The base151 further includes spaced retaining walls 161 for retaining the testelement, a block wall 163 to block rapid rate fluid, and a vent hole 165defined in the upper wall 153. The performance and the function of theretaining walls, block wall, and vent hole will be described in detailbelow.

The lid 101 can be coupled to the container 313 to seal the sample inthe container. Additionally, in the present invention, the coupling ofthe lid 101 to the container can also can be used to initiate an assay,which will be described in further detail below. In this embodiment thelid 101 includes a top 103 and a downwardly-extending flange 105 whichhas a shape that corresponding to the shape of the rim 113 of thecontainer 313 so that the flange can couple to the rim. In theembodiment depicted, the top 103 is formed with a circular depression107 having a bottom surface 201 that can depress the movable member 215while the lid 101 is being coupled to the container 313. A sealingmember 109, such as an O-ring can be positioned between the lid 101 andthe container 313 to provide a seal therebetween.

The test element can be in the form of a test card, which can be anytype of device that is configured to assay a sample. In this embodiment,the test element includes an assay card 119 for detecting the presenceor amount of an analyte in the sample and the device further includes anadulteration test card 131 for detecting the contamination of thesample. Each card 119 (131) has a size and shape that is configured tobe inserted into an upper portion 211 of the second chamber 601 of thedevice, and retained by the retaining walls 161 of the base 151. Inother embodiments the card can be retained by any suitable means withinthe second compartment 601. In various embodiments each card 119 (131)can have a panel 121 (133) with a group of slots 123 (135) definedtherein, a number of assay strips 125 or adulteration strips 137retained in the slots, and a cover 127 (139) adhered to one surface ofthe panel having windows 129 (141) for observing the test result.

The movable member 215 is movably present in a plunger housing 311. Inthis embodiment, the movable member is a plunger 215. The plunger 215includes an elongated push bar 147 extending through the upper portion307 of the plunger housing 311 toward the opening 115 of the container313, a plunger body 149 connecting one end of the push bar 147 andhaving a size and shape that is configured to be movable in the lowerportion 303 of the plunger housing 311, and a first sealing ring 143retained around the push bar 147 and a second sealing ring 145 retainedaround the plunger body 149. In the embodiment depicted in the Figuresthe sealing rings 143 and 145 have the form of circular rubber orplastic rings. But the sealing rings can be made of any suitablematerial and can take any shape that functions within the device.

With reference to FIGS. 5-9, in this embodiment the base 151 ispermanently fixed to the main body 111 to form an integral container313. In this assembled state, a first chamber 301 is defined in theinterior of the main body 111 for storing the liquid sample introducedthrough the opening 115. A second chamber 601 of the main body 111 canalso include a cavity portion 157 defined in part by the base 151, andan upper portion 211 for receiving the test element. A passageway 205 isprovided to permit the liquid sample to flow from the first chamber 115to the second chamber 601. The passageway is sized so that the surfacetension of the liquid sample will prevent the sample from flowing fromthe first to the second chamber until it is “pulled” or sucked into thesecond chamber by the vacuum created by depressing the plunger in thethird chamber. In the present embodiment, the passageway 205 is a smallsize bore as hereinbefore mentioned.

A third chamber 701 is defined in an interior of the plunger housing311, as shown in FIGS. 7 and 9, when the plunger 311 is received in theplunger housing 311, the first and second sealing rings, 143 and 145respectively, serve to provide a seal within the third chamber 701. Thethird chamber 701 contains a first zone 901 and a second zone 902, wherethe first zone is the area below the movable member and the second zoneis the area above the movable member. Therefore, the first and secondzones change in volume as the movable member is moved from one positionto a second position. When present, the sealing rings can divide thefirst zone from the second zone of the third chamber. In the embodimentdepicted, the first zone 901 is the space in the third chamber below thesecond sealing ring 145, and the second zone 902 is the space definedabove the first sealing ring 145 and below the second sealing ring 143.As the plunger 215 moves in the third chamber 701, the first and secondsealing rings, 143, 145 respectively, remain in contact with the innersurface of the upper and lower portions 303, 307, respectively, of theplunger housing 311 to prevent air communication between the first andsecond zones 901, 902. The channel 801 allows the passage of air fromthe second chamber to the third chamber as the movable member is loweredin the third chamber. The channel 801 can take any suitableconfiguration, but is conveniently present as an opening allowing aircommunication between the second chamber and third chamber.

Method of Use

In use, a liquid sample, such as urine, is first introduced into thefirst chamber of the container. Liquid sample placed into the firstchamber 115 will remain in the first chamber and will not flow throughthe passageway 205 since the surface tension of the liquid sample issufficient to prevent it from flowing through the passageway, untildrawn through by a vacuum force created in the second chamber 601.

The lid 101 is then coupled to the container 313, such as by screwingthe lid onto the container. With reference to FIG. 7, the plunger 215 islocated at a first, raised position at the beginning of the assay. Inthe first position, the top of the push bar 147 extends upward asufficient distance in the first chamber so that when the lid isapplied, the depression 107 in the lid will contact the top of the pushbar. The plunger body 149 is located in the lower section 303 of theplunger housing 311. In one embodiment the plunger body 149 abutsagainst a number of ribs projecting from an inner surface of theintermediate section 305. When the plunger is in the first, raisedposition, the volume of air in the second zone 902 of the third chamber701 is relatively small relative to the volume of air in the second zone902 when the plunger body 149 is in the second, lowered position.

When the lid 101 is screwed onto the container, the bottom surface 201of the circular depression 107 comes into contact with the top of thepush bar 147, and exerts a downward force on the push bar to actuatemovement of the plunger along its axial direction from the first, raisedposition to the second, lowered position. With the movement of theplunger from the first position to the second position, air is forcedfrom the first zone out of the vent hole. At the same time, a vacuum iscreated in the second zone, which causes air to be “pulled” in from thesecond chamber 601 into the second zone of the third chamber to fill thevacuum. This action thereby also creates a corresponding vacuum in thesecond chamber 601, which “pulls” fluid sample in the first chamber 115through the passageway 205 and into the second chamber 601 to neutralizethe vacuum, since the force of the vacuum is sufficient to overcome thesurface tension of the liquid sample over the passageway. This thereforecauses the fluid sample to contact the test elements in the upperportion 211 of the second chamber. The vent hole can be convenientlyconfigured as an opening that allows the passage of air, but can alsotake any other suitable configuration consistent with its function.

Referring to FIGS. 5 and 6, in one embodiment a barrier wall 163 islocated directly in the flow path of fluid coming into the secondchamber from the first chamber. This barrier wall 163 serves to block aportion of the liquid sample that enters the second chamber 601 andprevents the liquid sample from achieving a flow rate high enough tocause damage to the strips 125, 137 or flooding thereof. The barrierwall 163 requires the fluid to turn at a right angle before contactingthe test strips, therefore causing the liquid sample to slow down andcontact one end of each strip 125, 137 in a more orderly fashion. Thisfacilitates the liquid sample advancing through the test strip bycapillary action to the test line, and a visible result is shown in theresult window 129, 141. The sidewalls 117 of the container 313 can betransparent or semi-transparent to enable visual observation of thestrips therethrough.

As shown in FIG. 9, when the plunger 211 is moved from the firstposition to the second position, the liquid sample drawn into the secondchamber 601 is of a volume that adequately submerges the test strips butdoes not cause flooding. The plunger 211 can be set during manufactureso that movement from the first position to the second position draws inan appropriate amount of liquid sample. Additionally, the first positioncan also be preset in manufacture, but the second position can becontrolled by the user. For example, a mark can be provided as anindicator on the rim 113 to indicate that when the lid 101 screws tothis line the plunger has reached the second position. In thisembodiment, the second position can be reached when the lid 101 iscompletely coupled to the container 313. Thus, the user can begin theassay in a single step of securing the lid to the container, and thetest can be performed.

Example 1

This example illustrates the general use of a device of the invention.Water was poured into five devices of the invention configured as urinecups. After one hour the water sample remained in the first chamber ofthe cup and had not entered the second chamber by passing through thepassageway. The lids were then applied to the cups, thereby pressingdown the push bar and moving the plunger from the first position to thesecond position as the lid was applied.

After 5 minutes, it was observed that water had entered the secondchamber through the passageway. The water sample wetted the test stripswithout flooding them. The cup was then placed into a barometriccontainer and subjected to a barometric pressure of 0.7 for 3 minutes.No leaking was observed to occur.

Example 2

This example illustrates the use of a device of the invention to detectdrugs of abuse in human urine using a competitive assay. Thus, a linewould appear at the test line when no analyte was present in the sample.A test strip was included to test for the following analytes: THC,opiates (OPI), PCP, and methamphetamine (MET).

Samples of drug-free urine, urine at −50% cutoff, urine at +50% cutoff,and 3× cutoff were arranged. Each sample was analyzed in triplicateusing a device of the invention by placing the urine sample in the cupand fastening the lid, thus beginning the assay.

At 5 minutes of time, the results were observed. In the drug-free urinesample, a bright line was observed on the test line of all analytes forall three replicates, indicating a negative result for all analytes. Inthe −50% cutoff, a sample a line was observed for all analytes in allthree replicates, indicating a negative result for all analytes. In the+50% cutoff samples, either no line or a very faint line appeared ineach of the three replicates, indicating a positive result for allsamples. In the 3× cutoff samples, no line was visible indicating apositive result.

The invention illustratively described herein may be practiced in theabsence of any element or elements, limitation or limitations that arenot specifically disclosed herein. The terms and expressions which havebeen employed are used as terms of description and not of limitation,and there is no intention that in the use of such terms and expressionsof excluding any equivalents of the features shown and described orportions thereof, but it is recognized that various modifications arepossible within the scope of the invention claimed. Thus, it should beunderstood that although the present invention has been specificallydisclosed by various embodiments and optional features, modification andvariation of the concepts herein disclosed may be resorted to by thoseskilled in the art, and that such modifications and variations areconsidered to be within the scope of this invention as defined by theappended claims.

The contents of the articles, patents, and patent applications, and allother documents and electronically available information mentioned orcited herein, are hereby incorporated by reference in their entirety tothe same extent as if each individual publication was specifically andindividually indicated to be incorporated by reference. Applicantsreserve the right to physically incorporate into this application anyand all materials and information from any such articles, patents,patent applications, or other documents.

1. A device for detecting the presence of an analyte in a liquid sample,comprising: an opening for introducing the liquid sample into a firstchamber for collecting the liquid sample; a second chamber connected tothe first chamber by a passageway and containing a test element; a thirdchamber connected to the second chamber by a channel and containing amovable member having first and second positions, the third chamberbeing divided by the movable member into first and second zones and thefirst zone comprising a vent hole; the movable member in contact with atleast one wall of the third chamber to prevent gas communication betweenthe first and second zones.
 2. The device of claim 1 further comprisinga lid for closing the opening.
 3. The device of claim 1 wherein the testelement is an assay card containing one or more test strips.
 4. Thedevice of claim 1 wherein the movable member is a plunger.
 5. The deviceof claim 4 wherein the plunger contains a seal in contact with at leastone wall of the third chamber to prevent gas communication between thefirst and second zones.
 6. The device of claim 4 wherein the thirdchamber comprises a bottom and the vent hole is situated on the bottomof the third chamber.
 7. The device of claim 4 wherein the plungercomprises a push bar extending towards the opening.
 8. The device ofclaim 7 further comprising a lid having a surface that contacts anddepresses the push bar when the lid is applied to the opening.
 9. Thedevice of claim 1 wherein the passageway has a diameter of less than 8mm.
 10. The device of claim 9 wherein the passageway has a diameter ofless than about 4 mm.
 11. The device of claim 1 wherein the test elementcomprises at least one test strip.
 12. A method for detecting thepresence of an analyte in a liquid sample, comprising: introducing aliquid sample into a test device comprising an opening for introducingthe liquid sample into a first chamber for collecting the liquid sample;a second chamber connected to the first chamber by a passageway andcontaining a test element; a third chamber connected to the secondchamber by a channel and containing a movable member having first andsecond positions, the third chamber being divided by the movable memberinto first and second zones and the first zone comprising a vent hole;the movable member in contact with at least one wall of the thirdchamber to prevent gas communication between the first and second zones;causing the movable member to move from the first position to the secondposition and thereby causing a volume of air to be drawn from the secondchamber into the third chamber, and thereby causing a volume of liquidto be drawn from the first chamber through the passageway and into thesecond chamber to contact the test element; detecting the presence ofthe analyte in the sample.
 13. The method of claim 12 wherein the testelement comprises at least one test strip.
 14. The method of claim 12wherein the device further comprises a lid, and the method furthercomprises applying the lid to the device after introducing the sample.15. The method of claim 14 wherein the movable member is a plungerhaving a push bar, and the step of applying the lid comprises contactingthe lid with the push bar and depressing the push bar as the lid isapplied to the device, and thereby causing the movable member to movefrom the first position to the second position.
 16. The method of claim15 wherein depressing the push bar and moving the movable member fromthe first position to the second position causes a negative air pressuregradient to form in the third chamber and the volume of air to be drawnfrom the second chamber into the third chamber.
 17. The method of claim16 wherein the movement of the volume of air from the second chamber tothe third chamber causes a negative air pressure gradient to form in thesecond chamber.
 18. The method of claim 17 wherein the negative airpressure gradient in the second chamber causes the fluid sample to flowfrom the first chamber through the passageway to the second chamber, andthereby to contact the test element.
 19. The method of claim 15 whereindepressing the push bar and moving the movable member from the firstposition to the second position causes a volume of air to escape fromthe first zone through the vent hole.